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21 CFR Part 11, GxP Technology Compliance and Computer Validation Solutions
   Validation & Compliance
   Services
valimationi 21 CFR Part 11 Practice
valimationi IT Infrastructure
   Qualification Practice
valimationi GMP/GLP/GCP Validation    Practice
valimationi Compliance Consulting &    Auditing Practice
valimationi Vendor Solutions
 
   Systems Integration
valimationi Business Process
   Automation
valimationi Plant Automation
valimationi Traceability Solutions
valimationi ERP Systems

Provided consulting services to Pathlore in the development of a Part 11 compliant Learning Management System. ValiMation jointly worked with Pathlore's technical and marketing teams to interpret 21 CFR Part 11, specific to the Learning Management System.
Jim Whipkey, Pathlore
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It Infrastructure Qualification Practice

We work with equipment and software vendors providing solutions and products to the FDA regulated industries.  We provide wide range of services to meet the specific needs of the vendors catering to the GxP companies.  Value Proposition..

Valimation What vendor services do we provide?

Valimation Develop a validation and compliance suite (Requirements & Specifications,
    Manuals, SOPs, Training Documents, Validation Protocols, Configuration Best
    Practices) specific to the implementation of your product. Read more..

Valimation Develop custom validation packages for your clients in an expedient and cost
    effective manner.

Valimation Support your client’s onsite protocol executions at a very reasonable price

Valimation Provide consulting services to marketing and application development groups
    for developing 21 CFR Part 11 compliant software products. These may include:

  • Develop Part 11 Requirement Specifications
  • Provide Software Technical Support
  • Develop Software Modules
  • Certify Final Versions for Part 11 Compliance.

Valimation Develop white papers to demonstrate Part 11 compliance.

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